Federal programs such as the Vaccines for Children (VFC) program provide federally-funded vaccines to private pediatric practices via state agencies. The state agencies are responsible for collecting and monitoring temperature data provided by the private pediatric personnel.
Until recently, the data was often written down twice daily by office personnel and reviewed periodically by state health inspectors when they made routine inspection visits to the practice.
Very recently there has been an increasing awareness that these drugs are not being monitored sufficiently. There is a strong sense of urgency to ensure the drugs are still effective at the time they are administered to patients.
Several states are attempting to find better solutions address these problems. One state, in particular, has provided temperature logging devices to all the VFC pediatric practices within that State. The devices are attached to the refrigerators that contain the VFC vaccines and require the health care providers to remove the devices from the refrigerators on a weekly basis and connect them to USB docking stations attached to their office computers. Upon connection, the devices generate plain text files consisting of temperature and time data structured as columns delimited by commas or Comma Separated Value (CSV) files. These plain text files are then uploaded to the state VFC database. There are several obvious problems with this method. The CSV file can be manipulated prior to uploading to state or federal agencies and it is a never-ending tedious cycle that places additional burdens on office personnel. Additionally, the temperature is not being monitored for the duration of data acquisition using USB docking station and no data is available in the intervals between device docking. Thus, the data only identifies temperature problems several days after they have already occurred. If a problem is detected, the pediatric practice is financially responsible for replacing the entire stock of vaccines and drugs. A typical home-style refrigerator can easily store several hundred thousand dollars' worth of vaccines.
A mandate requiring continuous and automatic temperature monitoring with alarm reporting capabilities is inevitable. However, even before this mandate becomes effective, doctors and state officials are searching for reliable solutions to protect vaccines from damage due to poor temperature conditions. In order to enforce the safety procedures, officials must obtain uncompromised temperature data and not rely on data that can be manipulated or destroyed by the health care providers. In order for health care providers to respond to temperature problems before damage occurs, they must receive alert notifications and physically respond in a timely manner. Because life, health, and great financial costs are at risk, a secure audit trail of all temperature data, alert notifications, alert acknowledgements, and physical response confirmations is critical to ensure optimum safety and accountability. In some embodiments, a temperature graph is presented to staff before the staff acknowledges and/or signs a temperature inspection report. It forces them to view useful data and not a single numeric temperature which represents only a single moment in time
During the normal operation of typical home-style refrigerators air temperatures fluctuate greatly when the compressors cycle on and off. Additionally, the air temperatures also fluctuate greatly when the doors are opened and closed. Because the process of monitoring temperature data by officials (and the logging of the data itself) was previously a manual hands-on process, it was very difficult to analyze this data in a manner that would indicate the true average temperature of the refrigerator and ultimately the vaccines.
For this reason, federal guidelines require that the temperature measuring devices are placed in a buffered solution such as propylene glycol. A bottle of glycol increases the physical mass of the temperature probe and ultimately slows down the response time providing a flatter, more stable temperature reading.
The obvious drawback of this method is a delayed detection of a genuine refrigeration system problem.
In addition to these temperature-detection shortcomings, all temperature alarm systems known to date simply send unconfirmed alert messages via SMS, email, or voice calls. No system known to date provides operator accountability by acknowledging that the alert messages are actually received by the intended recipient.
Furthermore, even if the recipient is known to have received the alert message, no system known to date confirms that a physical response procedure has been performed in a timely manner.
Other systems typically use the health-care provider's internet connectivity and will not operate when the internet or utilities fail. Some systems are cellular-only but none known to date operates in dual mode, using the provider's internet as a primary source, but only reverting to cellular when the primary connection fails.
What is needed is a system that will monitor temperatures within refrigeration units and provide reporting, alerts, and predictive analysis.